QA Technical Services Specialist (2nd Shift)

QA Technical Services Specialist (2^nd Shift)

WHO?:

This role is a great opportunity to work with Quality Control (QC) personnel but within the realm of Quality Assurance. The candidate will have the opportunity to learn about the equipment used to perform testing as well as the different methods for performing each test. The ideal candidate will be able to communicate with the other data reviewers to ensure adherence to quality standards.

The Quality Assurance Technical Services (QATS) Specialist is responsible for reviewing and approving QC and Incoming Quality Control (IQC) documentation. This documentation includes data from QC Microbiology, Chemistry, IQC and Method Transfer. The QATS Technical Services Specialist will work in coordination with Quality Control Technical Services (QCTS) to perform periodic walkthroughs of the QC laboratories to ensure good laboratory practices are followed and the areas meet regulatory inspection readiness.

This position will support primarily second shift (3:00-11:30pm).

WHAT?

• Perform laboratory data review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry, Microbiology, IQC and Method Transfer.
• Partner with Quality Control in the data analysis and data review process.
• In coordination with QA and QC management, use knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC laboratories.
• Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc.) to ensure data integrity for all Quality Assurance and Quality Control site policies, procedures, and testing records.
• Use technical skills and applied statistics to analyze and identify sources of variability and error in QC processes.

YOU:

Ideally, candidates will have a Bachelor’s degree in Science (Chemistry, Biology, Microbiology, or Biochemistry), or 5 years of relevant GMP experience, as well as the following:

• 4+ years’ experience of GMP biopharma industry experience, with at least 1 year experience with isolator-based aseptic manufacturing environments required.
• Experience as a technical data reviewer in a GMP regulated industry.
• High level of understanding and oversight of Quality Control testing processes for aseptic manufacturing.

Intrigued? Send us your resume at apply@leadcandidate.com or you can find more information here: QA Technical Services Specialist (2nd Shift)

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.